Efficacy of ozone therapy on visual evoked potentials in diabetic patients.

BACKGROUND: The involvement of the central nervous system is a frequent yet underestimated complication of diabetes mellitus. Visual evoked potentials (VEP) are a simple, sensitive, and noninvasive method for detecting early alterations in central optic pathways. The objective of this paralleled randomized controlled trial was to evaluate the impact of ozone therapy on visual pathways in diabetic patients. METHODS: Sixty patients with type 2 diabetes visiting clinics of Baqiyatallah university in Tehran (Iran) hospital were randomly assigned to two experimental groups: Group 1 (N = 30) undergoing a cycle of 20 sessions of systemic oxygen-ozone therapy in addition to standard therapy for metabolic control; Group 2 (N = 30)-serving as control-receiving only standard therapy against diabetes. The primary study endpoints were two VEP parameters; P100 wave latency and P100 amplitude at 3 months. Moreover, HbA1c levels were measured before the start of treatment and three months later as secondary study endpoint. RESULTS: All 60 patients completed the clinical trial. P100 latency significantly reduced at 3 months since baseline. No correlation was found between repeated measures of P100 wave latency and HbA1c (Pearson's r = 0.169, p = 0.291). There was no significant difference between baseline values and repeated measures of P100 wave amplitude over time in either group. No adverse effects were recorded. CONCLUSIONS: Ozone therapy improved the conduction of impulses in optic pathways of diabetic patients. The improved glycemic control following ozone therpay may not fully explain the reduction of P100 wave latency though; other mechanistic effects of ozone may be involved.

Response of transplant recipients to influenza vaccination based on type of immunosuppression: A meta-analysis.

Influenza vaccination is widely used in transplant recipients, but there is little known about the significance and correlating factors of its effectiveness. In the current study, we reviewed the existing literature on clinical trials performed in transplant recipients on the effectiveness of influenza vaccination and to evaluate the relevance of the type of immunosuppression employed in these patients on the humoral reaction to the vaccine. A comprehensive search of the literature was performed through Pubmed and Google Scholar to find reports indicating immunogenicity of influenza vaccination in transplant patients. Finally, data from 15 published clinical trials were included in the meta-analysis. Data of 947 transplant recipients retrieved from 15 clinical trials investigating the immunogenicity of influenza vaccination were analyzed in this meta-analysis. Analysis showed significantly lower rates of sero-conversion among transplant recipients receiving mycophenolate mofetil (MMF) than other immunosuppressive agents (relative risk: 0.724; 95% confidence interval: 0.596-0.880; P = 0.001). No significant correlation was found with tacrolimus, sirolimus, cyclosporine and azathioprine. Different immunosuppressive agents seem to have different effects on the humoral response rate to influenza vaccination, with MMF having the most significant deleterious effect. The limited and controversial data available in the literature do not support any differential effect for other immunosuppressive agents.

Chlamydia pneumoniae in the atherosclerotic plaques of coronary artery disease patients.

An association between Chlamydia pneumoniae (C. pneumoniae) and cardiovascular disease has been demonstrated. In this study, we aimed to study this potential relationship in 105 Iranian patients. Coronary artery specimens from 105 Iranian patients undergoing CABG were analyzed by PCR method for C. pneumoniae. Serological evaluation for C. pneumoniae IgG and IgM was performed using ELISA. 53 specimens from mamillary artery were also investigated. C. pneumoniae PCR test result was positive for 23 (21.9%) of patients with coronary artery atherosclerosis, but none of the specimens from the mamillary artery was positive for C. pneumoniae when it was evaluated by the PCR (P<0.001). Coronary artery disease patients with and without a history of unstable angina or myocardial infarction were comparable in C. pneumoniae PCR test positive rates (P=0.618). Relevance of IgG and IgM positivity were also studied by correlating it to the study parameters, but no difference was found. CRP was significantly higher in the IgM positive group (P<0.001). A significant proportion of coronary atherosclerotic plaques are infected with C. pneumoniae while no infection was found in the normal mamillary artery specimens. No association was found between acute coronary syndromes and serological and PCR positivity. Further prospective randomized controlled studies with large patient population are needed to confirm our findings.

Cytomegalovirus localization in atherosclerotic plaques is associated with acute coronary syndromes: report of 105 patients.

It has been shown that cytomegalovirus (CMV) is present in coronary atherosclerotic plaques, but the clinical relevance of this presence remains to be elucidated. In this study we sought to examine CMV infection in atherosclerosis patients defined by different methods and to identify the clinical significance of CMV replication in the atherosclerotic plaques. The study included 105 consecutive patients who were admitted to our department and underwent coronary artery bypass grafting (CABG) surgical interventions. Coronary atherosclerotic specimens as well as 53 specimens from the mamillary artery of these same patients were analyzed. Enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR) methods were used for evaluations. The CMV PCR test result was positive for 28 (26.7%) of patients with coronary artery atherosclerosis. After adjusting for other risk factors, coronary artery disease patients with a history of acute coronary syndrome were more likely to be positive for CMV PCR test (P=0.027; odds ratio: 4.2; 95% CI: 1.18-15.0). They were also more likely to have a positive family history for cardiovascular diseases (CVD). This study confirms previous evidence about the replication of CMV virus in the atherosclerotic plaques of coronary arteries and brings clinical significance to this observation by showing a higher prevalence of acute coronary syndromes in those patients with CMV-infected plaques. Our study also suggests a familial vulnerability to CMV replication in the coronary artery walls.

Informed consent for inclusion into clinical trials: a serious subject to note in the developing world.

INTRODUCTION: Informed consent is a critical issue especially in conducting clinical trials that expose human life to medical or surgical interventions. It necessitates a long and complex process through which the participant is presented with all potential favorable and non-favorable consequences upon getting enrolled in the study. REVIEW: The process of taking informed consent is well-understood in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of whether to participate or not. This may not be the case in the developing world.The information given to patients before the trial might not be properly developed and presented, an issue that can result in serious threat to the decision-making process. On the other hand, investigators should remember that enrolling people into a trial with no potential benefit for themselves cannot be considered ethical. In the current debate, we aim to address the issue of how respectfully and ethically clinical research trials can be done on human subjects and what we can do to enhance the practice in an ethical context. CONCLUSION: Development of a system through which we could warrant all rights of study participants in all cases around the world seems far from view. However, if we are in doubt about the ethics of a clinical trial, we can ask ourselves: "what would we do, if we were in the same position our patients are in now?"

Bone marrow involvement by lymphoproliferative disorders after renal transplantation: PTLD. Int. Survey.

CONTEXT: Renal graft recipients who develop post-transplant lymphoproliferative disorders (PTLD) that complicate bone marrow (BM). AIMS: To investigate features, predictors and prognosis of BM involvement by PTLD in renal transplant patients. SETTINGS AND DESIGN: A comprehensive search for the available data though PubMed and Google Scholar for reports of PTLD localization in BM in renal allograft recipients. MATERIALS AND METHODS: Data of 168 PTLD cases in renal transplant context who have developed bone marrow PTLD gathered from 18 studies and were pooled and analyzed. STATISTICAL ANALYSIS USED: Chi-square test, Student's t test and fissure's exact test were employed. RESULTS: Chi-square test showed that renal recipients with BM PTLD were significantly more likely to represent multi-organ disease (P<0.001), and disseminated PTLD (P<0.001). BM PTLD was also more frequently seen among pediatric renal recipients who had developed PTLD (P=0.016). PTLD, in BM PTLD renal recipients more significantly complicated liver (P=0.008), but less commonly affected skin (P=0.045). BM PTLD lesions were relatively more likely to be of monomorph phenomenon (P=0.06). CONCLUSIONS: Renal recipients with BM PTLD represent worse outcome and more unfavorable histopathological phenomenon than in other organ involvements. Moreover, a concomitant PTLD involvement site in liver was found which necessitates full hepatic evaluation for a potential complication by the disease in renal recipients whose BM is involved.

Hepatic involvement by lymphoproliferative disorders post liver transplantation: PTLD.Int. Survey.

BACKGROUND: It is speculated that different localizations of lymphoproliferative disorder after solid organ transplantation (PTLD) have different features and represent specific behavior as well as prognostic individualities. OBJECTIVES: To compare characteristics of hepatic PTLD (H-PTLD) with non-hepatic PTLD (NH-PTLD) in liver transplant recipients. MATERIALS AND METHODS: We searched PubMed and Google Scholar for all published reports of PTLD in liver recipients within their liver. Reported characteristics of H-PTLD and NH-PTLD were compared. RESULTS: A total of 21 studies from various countries were found. Overall, 169 liver recipients with PTLD were included in the analysis, of whom 83 (49%) had H-PTLD. Patients with H-PTLD were more likely to test positive for Epstein-Barr virus (EBV) (p < 0.0001), be older at the time of transplantation (p = 0.009), have a shorter time to PTLD development (80 vs. 41% early-onset PTLD; p < 0.001), and have bone marrow involvement (p = 0.03). Multivariate linear regression showed that H-PTLD and EBV positivity, but not age at transplant, were independently associated with time to PTLD development (p = 0.003, p < 0.0001, and p = 1.0, respectively). CONCLUSIONS: Liver transplant patients exhibiting early deterioration of graft function or other hepatic symptoms should, in addition to assessment for rejection, be evaluated for H-PTLD. In addition, all H-PTLD patients should be evaluated for bone marrow involvement, especially if they are EBV positive. Prospective studies with large patient populations are needed to confirm our results.

Radiotherapy is the best treatment method in post transplant lymphoproliferative disorders localizing in brain: a review of the literature.

BACKGROUND: Localization of post transplant lymphoproliferative disorders (PTLD) in the central nervous system (CNS) is a rare but life-threatening complication of transplantation. In the current study, we sought to aggregate data of PTLD in the series existing in the literatures on brain localization of PTLD and to concentrate on the management methods of the disease to compare and find the best treatment strategies in these patients. MATERIAL/METHODS: We conducted a thorough search of the literature to find treatment strategies employed to manage CNS involvement by PTLD. Data were pooled and standardized and reanalyzed. RESULTS: Overall 79 patients with CNS PTLD were entered into analysis. Patients undergone radiotherapy represented a significant superior outcome compared to that of patients who had not received radiotherapy (p<0.05). other treatment strategies had no significant impact on the survival (p>0.2 for all). One and five years survival rates for CNS involved PTLD patients who underwent radiotherapy were 71% and 37%, respectively; compared to 41% and 28%, respectively, for the control group. CONCLUSIONS: In the current study, we found that radiotherapy is an effective method of treatment for organ recipients who develop PTLD within central nervous system during their post transplant period. No beneficial effect for chemotherapy, interferon alfa, or a combination of them with radiotherapy was detected. We recommend using radiotherapy in all transplant patients developing CNS PTLD.